MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRUETOME¿ JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00583100

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a truetome¿ jag 44 was used in the distal common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the tome appeared "skew" when it came out, which was needed a little turn in order to correct; however, the cannulation was not successful.The tome was then removed and a non bsc device was used, wherein a precut was made in order to access the papilla.There was no issue during that time.The truetome¿ jag 44 was then reinserted and was cannulated successfully.After a while, bleeding was noticed at the distal part of the cbd and blood came out from the papilla.Cold water was used through the scope which stopped the bleeding.In order for them to assess the bleeding site, the tome was removed out from the cbd.When it was finally out from the papilla, the physician noticed a "hook" on the tome.He decided not to remove the "hook" through the working channel, so he removed the scope completely and have the "hook" checked and looked what this really was.It was then found out that the "hook", which was found out stuck on the outside tip of the tome, was the tip of the guidewire.The physician believed that the detachment of the tip of the guidewire has something to do with the cause of the bleeding of the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over 18 years old.Reported event of guidewire distal tip detached exposing the tip of the metal corewire.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Manufacturer Narrative

Result: operational problem is being used to capture the issue distal tip of the guidewire was partially detached.Investigation results of the preloaded guidewire: visual evaluation of the returned guidewire found that it has distal end damage, which presents distal tip partially detached; however, the corewire is not exposed.Based on the available information, the complaint is associated with a product that meets the specification but due to anatomical or procedural factors encountered during the procedure, performance was limited.Therefore the most probable root cause of the issues found is operational context.A search of the complaint database revealed that no other complaints exist for the specified lot.The device history record review found the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that a truetome¿ jag 44 was used in the distal common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the tome appeared "skew" when it came out, which was needed a little turn in order to correct; however, the cannulation was not successful.The tome was then removed and a non bsc device was used, wherein a precut was made in order to access the papilla.There was no issue during that time.The truetome¿ jag 44 was then reinserted and was cannulated successfully.After a while, bleeding was noticed at the distal part of the cbd and blood came out from the papilla.Cold water was used through the scope which stopped the bleeding.In order for them to assess the bleeding site, the tome was removed out from the cbd.When it was finally out from the papilla, the physician noticed a "hook" on the tome.He decided not to remove the "hook" through the working channel, so he removed the scope completely and have the "hook" checked and looked what this really was.It was then found out that the "hook", which was found out stuck on the outside tip of the tome, was the tip of the guidewire.The physician believed that the detachment of the tip of the guidewire has something to do with the cause of the bleeding of the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Note: the investigation of this device is performed at two different sites.Investigation of the tome portion of the truetome device at spencer cis has been performed and the results are provided below.Investigation of the pre-loaded jagwire from the truetome device will be performed at (b)(4).Upon completion of the (b)(4) cis investigation, if there is any further relevant information from that review, a supplemental medwatch will be filed.Result: the reported event of guidewire tip detachment will be investigated at (b)(4); the result code - operational problem is being used to capture the bent cutting wire, torn tip, and peeled paint marker on the tip of the truetome.Conclusion: the root cause determination for the reportable event (detachment of guidewire tip) will be investigated at (b)(4); therefore, the conclusion code for the reported event is unknown at this time.Investigation results of truetome: visual evaluation of the returned truetome found that the cutting wire was bent, the tip was torn and the paint marker on the tip was peeled.Functionally, the truetome bowed fully and in plane.A search of the complaint database revealed that no other complaints exist for the specified lot.The device history record review found the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that a truetome¿ jag 44 was used in the distal common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the tome appeared "skew" when it came out, which was needed a little turn in order to correct; however, the cannulation was not successful.The tome was then removed and a non bsc device was used, wherein a precut was made in order to access the papilla.There was no issue during that time.The truetome¿ jag 44 was then reinserted and was cannulated successfully.After a while, bleeding was noticed at the distal part of the cbd and blood came out from the papilla.Cold water was used through the scope which stopped the bleeding.In order for them to assess the bleeding site, the tome was removed out from the cbd.When it was finally out from the papilla, the physician noticed a "hook" on the tome.He decided not to remove the "hook" through the working channel, so he removed the scope completely and have the "hook" checked and looked what this really was.It was then found out that the "hook", which was found out stuck on the outside tip of the tome, was the tip of the guidewire.The physician believed that the detachment of the tip of the guidewire has something to do with the cause of the bleeding of the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TRUETOME¿ JAG 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4896185
• MDR Text Key: 6537897
• Report Number: 3005099803-2015-01938
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/11/2016
• Device Model Number: M00583100
• Device Lot Number: 17192713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1